Executive Director, Quality Enablement CPS
5 days ago
Dallas
The CPS organization is seeking a Senior Director or Executive Director, Quality Enablement to provide enterprise-level leadership in defining, governing, and advancing quality oversight across early-phase and pharmacology studies. This role is critical to shaping CPS quality strategy and positioning quality as a strategic differentiator for sponsors. Job Overview This executive leader partners closely with CPS Executive Leadership and key cross-functional stakeholders-including Clinic Operations, Project Management, Data & Analytics, Quality, and Technology-to embed Quality by Design (QbD) and proactive, risk-based quality management into CPS study delivery models. The Senior/Executive Director is accountable for ensuring that CPS operational processes, standards, and training programs are fit-for-purpose, scalable, and inspection-ready, while fully aligned with global regulatory expectations. This role drives a forward-looking quality enablement framework that supports innovation, accelerates early-phase development, and strengthens sponsor confidence. As a strategic advisor to senior leadership, this individual influences enterprise decision-making, leads change at scale, and ensures consistent, high-quality execution across CPS environments. . Summary of Responsibilities: CPS Quality Enablement Strategy & Governance • Define and own the CPSspecific quality enablement strategy, ensuring alignment with Fortrea enterprise quality standards and regulatory guidance (FDA, EMA, ICH E6/E8 R1)., • Establish quality enablement governance models, standards, and operating procedures tailored to CPS study designs, clinicbased execution, and earlyphase risk profiles., • Provide oversight of quality enablement execution across the CPS clinical trial portfolio, including firstinhuman, SAD/MAD, bioavailability, bioequivalence, and other clinical pharmacology studies., • Ensure consistent development, approval, and oversight of Integrated Quality Risk Management Plans (IQRMPs) strategies., • Lead, coach, and develop quality enablement leaders and teams embedded within CPS, building sustainable capability across clinics and delivery teams., • Partner with CPS leadership on workforce planning, capability development, and succession planning related to quality and quality enablement roles., • Act as a trusted advisor to CPS senior and executive leadership on quality enablement strategy, quality risk posture, and inspection readiness., • Collaborate with Clinic Operations, Project Management, Data Management, Biostatistics, Safety, and Quality to embed quality enablement into CPS delivery models., • Serve as a senior CPS quality enablement representative in RFPs, RFIs, bid defenses, and sponsor governance meetings., • Articulate Fortrea's CPSspecific quality enablement value proposition, demonstrating differentiation in earlyphase quality oversight and execution., • Lead continuous improvement of CPS processes, tools, templates, and training materials., • Sponsor and lead change management initiatives to mature quality enablement adoption across CPS clinics and project teams., • Bachelor's degree required; advanced degree preferred., • 10+ years of experience in clinical research, quality, or related fields (CRO, pharma, biotech)., • 5+ years of progressive leadership experience in, quality management or process improvements, preferably within earlyphase or clinical pharmacology environments., • Demonstrated experience leading global, crossfunctional CPS teams and influencing senior stakeholders., • Extensive sponsorfacing experience, including executivelevel interactions., • Strong understanding of CPS study designs, clinic operations, and earlyphase regulatory expectations., • Proven experience with audits, inspections, CAPA, and quality governance., • Deep expertise in quality enablement and CPS study execution, • Strong executive presence with the ability to influence without authority, • Advanced data analytics and risk signal interpretation capability, • Strategic leadership combined with strong operational execution, • Excellent communication, presentation, and stakeholder management skills, • Change leadership and organizational transformation capability Work Environment: • Work is performed in an office environment with exposure to electrical office equipment., • Frequently stationary for 6-8 hours per day., • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists., • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck., • Ability to access and use a variety of computer software developed both in-house and off-the-shelf., • Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs., • Regular and consistent attendance., • Varied hours may be required. Learn more about our ___.